ID

38859

Description

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form records whether the subject will return for the next Visit (to be recorded at Visits 1 and 2), whether the subject failed screening (to be recorded at Visits 1 through to 3) and the Investigator Signature at Visits 1 to 3.

Link

https://clinicaltrials.gov/ct2/show/NCT00992160

Keywords

Versions (2)
  1. 3/1/19 3/1/19 -
  2. 11/10/19 11/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 10, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

English

Study Continuation, Screen Failure, Investigator Signature

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit/Assessment
Description

Date of Visit/Assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Site
Description

Study site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Type of Visit
Description

At Visit 1 (Screening) and 2, fill in all three itemgroups. At Visit 3, fill in "Screen Failure" and "Investigator Signature" only.

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Prompt
Description

Prompt

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Will the subject continue to the next visit?
Description

Applicable to Visit 1 and 2 only

Data type

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
Screen Failure
Description

Screen Failure

Alias
UMLS CUI-1
C1710476
Was this subject a screen failure?
Description

If yes, record date and check all reasons that apply.

Data type

boolean

Alias
UMLS CUI [1]
C1710476
Screen Failure Date
Description

Screen Failure Date

Data type

date

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0011008
Did not meet inclusion/exclusion criteria
Description

Reason for Screening Failure: Inclusion/Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0566251
UMLS CUI [3,2]
C1710476
Investigator Discretion
Description

Specify in next item

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1710476
UMLS CUI [2,1]
C0008961
UMLS CUI [2,2]
C0022423
Investigator Discretion, specify
Description

Reason for Screening Failure: Specify investigator Discretion

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1710476
UMLS CUI [2,1]
C0008961
UMLS CUI [2,2]
C0022423
UMLS CUI [2,3]
C1521902
Failed PSG inclusion criteria on Central PSG judgement
Description

Reason for Screening Failure: Failed Polysomnography inclusion criteria on sponsor judgement

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1710476
UMLS CUI [2,1]
C0162701
UMLS CUI [2,2]
C1512693
UMLS CUI [2,3]
C0231175
UMLS CUI [2,4]
C2347796
UMLS CUI [2,5]
C0022423
Failed PSG inclusion criteria on Investigator judgement
Description

Reason for Screening Failure: Failed Polysomnography inclusion criteria on Investigator judgement

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1710476
UMLS CUI [2,1]
C0162701
UMLS CUI [2,2]
C1512693
UMLS CUI [2,3]
C0231175
UMLS CUI [2,4]
C0008961
UMLS CUI [2,5]
C0022423
For Data Managers or Monitors only: Require the investigator to re-sign the case book
Description

By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as licking and submitting if; that is, the signature will be invalidated in both instances.

Data type

boolean

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C1514873
Investigator Signature
Description

Investigator Signature

Alias
UMLS CUI-1
C2346576
Is this casebook ready to sign?
Description

Only select if casebook is ready to sign/finished. Original comment: "If not, click on the RETURN button below"

Data type

boolean

Alias
UMLS CUI [1]
C2346576
For Data Managers or Monitors only: Require the investigator to re-sign the case book
Description

By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state. This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as licking and submitting if; that is, the signature will be invalidated in both instances.

Data type

boolean

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C1514873
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Similar models

Study Continuation, Screen Failure, Investigator Signature

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Item
Type of Visit
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Type of Visit
CL Item
Visit 1 (Screening) (Visit 1 (Screening))
CL Item
Visit 2 (Visit 2)
CL Item
Visit 3 (Visit 3)
Item Group
Prompt
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Study Continuation
Item
Will the subject continue to the next visit?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item Group
Screen Failure
C1710476 (UMLS CUI-1)
Screen Failure
Item
Was this subject a screen failure?
boolean
C1710476 (UMLS CUI [1])
Screen Failure Date
Item
Screen Failure Date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Reason for Screening Failure: Inclusion/Exclusion Criteria
Item
Did not meet inclusion/exclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0566251 (UMLS CUI [3,1])
C1710476 (UMLS CUI [3,2])
Reason for Screening Failure: Investigator Discretion
Item
Investigator Discretion
boolean
C0566251 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
Reason for Screening Failure: Specify investigator Discretion
Item
Investigator Discretion, specify
text
C0566251 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
C0008961 (UMLS CUI [2,1])
C0022423 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
Reason for Screening Failure: Failed Polysomnography inclusion criteria on sponsor judgement
Item
Failed PSG inclusion criteria on Central PSG judgement
boolean
C0566251 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
C0162701 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C2347796 (UMLS CUI [2,4])
C0022423 (UMLS CUI [2,5])
Reason for Screening Failure: Failed Polysomnography inclusion criteria on Investigator judgement
Item
Failed PSG inclusion criteria on Investigator judgement
boolean
C0566251 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
C0162701 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0008961 (UMLS CUI [2,4])
C0022423 (UMLS CUI [2,5])
Investigator Re-Sign required
Item
For Data Managers or Monitors only: Require the investigator to re-sign the case book
boolean
C2346576 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Is this casebook ready to sign?
boolean
C2346576 (UMLS CUI [1])
Investigator Re-Sign required
Item
For Data Managers or Monitors only: Require the investigator to re-sign the case book
boolean
C2346576 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
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